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Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery

Primary Purpose

Abdominal Aortic Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Structured exercise programme
Sponsored by
Torbay and South Devon NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring exercise programme

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male participants ≥ 18
  2. Under surveillance as part of the AAA screening or surveillance programme with an AAA that is between 4.5 cm and 5.4 cm
  3. Able and willing to provide informed consent
  4. Understand verbal and written instructions in English
  5. Able to safely perform a cardiopulmonary exercise test (this will confirm they can use a cycle ergometer)
  6. Patients who are already participating (or have participated) in other trials may be eligible, but the relevant trial teams must agree this in advance.-

Exclusion Criteria:

  1. Contra-indications to exercise (lower limb amputation without prosthesis, bone, joint or muscle problem which may be exacerbated by exercise, chronic lung disease causing desaturation with exercise or shortness of breath at rest, severe psychiatric health problems)
  2. Cardiovascular contra-indications (unstable angina, acute left ventricular failure, uncontrolled cardiac arrhythmias, uncontrolled hypertension, cardiac event in the previous 6 weeks, cerebral vascular accident in the previous 6 weeks)
  3. Participation in other treatment trials, where this has not been agreed in advance with both trial teams
  4. Symptomatic AAA
  5. Urgency of surgery for AAA precludes undertaking exercise programme. -

Sites / Locations

  • Torbay HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Structured Exercise Programme

Arm Description

An initial 45 min exercise counselling incorporating behaviour modification techniques. Participants will be offered three sessions per week of aerobic interval exercise on a cycle ergometer over nine weeks. Exercise programmes will be tailored to each patient, taking previous level of activity, mobility and any barriers to exercise into consideration. Following this: Participants will be encouraged to comply with current physical activity recommendations: 150 min of moderate intensity aerobic exercise per week (brisk walking / cycling). They will also be sign posted to local exercise facilities.

Outcomes

Primary Outcome Measures

Change in predicted mortality: 30- day postoperative mortality (%) or median survival (years).
We can predict survival after planned abdominal aortic aneurysm (AAA) surgery using physical fitness measured with a cardiopulmonary exercise test, age and comorbidities. We have validated this in a published peer reviewed multicentre study. We will measure patient's fitness before and after a structured exercise programme and assess if there is any change in their predicted survival. The primary objective of the study is to measure the change in predicted survival for abdominal aortic aneurysm surgery after a structured exercise programme.

Secondary Outcome Measures

Change in Health related Quality of Life (HRQoL) scores
Metric: Completion of EuroQol EQ5D-5L questionnaires before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Change in Psychological Health Status
Metric: Completion of Hospital Anxiety and Depression (HAD) questionnaire before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Change in weight
Metric: Change in weight before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Change in cardiopulmonary exercise test
Metric: Change in cardiopulmonary fitness variables (VO2, anearobic threshold, VE/VCO2,oxygen pulse), as measured using an incremental Cardiopulmonary exercise test (CPET) before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Change in smoking status
Metric: Change in smoking habits (stopped, reduced) before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme

Full Information

First Posted
June 4, 2019
Last Updated
July 25, 2022
Sponsor
Torbay and South Devon NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03985202
Brief Title
Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery
Official Title
Can a Structured Exercise Programme Improve the Predicted Survival for Planned Abdominal Aortic Aneurysm Surgery Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Torbay and South Devon NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is a relationship between aerobic fitness and survival both with and without surgery. Some patients can improve their aerobic fitness with a structured exercise programme but currently it is not know how much this could change predicted survival for patients with an abdominal aortic aneurysm, or how long this change can be maintained. Survival can be predicted after planned abdominal aortic aneurysm (AAA) surgery using physical fitness measured with a cardiopulmonary exercise test. The researchers have validated this in a published peer reviewed multicentre study. In this study the patient's fitness will be measured before and after a structured exercise programme and assess if there is any change in their predicted survival. The primary objective of the study is to measure the change in predicted survival for abdominal aortic aneurysm surgery after a structured exercise programme. In addition the patients are asked to complete the following questionnaires:- EQ-5D-5L, Hospital Anxiety and Depression Scale (HADS) before and after the exercise programme.
Detailed Description
The UK has a national AAA screening programme. At the age of 65 men are offered a one off ultrasound test to look for a AAA. If their abdominal aorta is > 5.5 cm they are referred to a Vascular Surgeon. If the patients abdominal aorta is between 3 cm and 5.4 cm they are offered further ultrasound scans to monitor the size of their aorta. This is a surveillance programme. In addition men who have an AAA between 3 cm and 5.4 cm that is detected by an ultrasound scan, CT or MRI performed as part of an investigation for another clinical problem are added to the surveillance programme. In Torbay and South Devon men in the AAA surveillance programme are referred for a Cardiopulmonary Exercise Test when the AAA reaches 4.5 cm as part of standard clinical practice. This takes place in the Pre assessment Clinic in Torbay Hospital and is performed by a Consultant Anaesthetist. If the patient is able to safely perform the Cardiopulmonary Exercise Test they will be identified as potential participants by the Consultant Anaesthetist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
exercise programme

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomised interventional observational study. Pilot study. 60 patients to be recruited from the Torbay AAA screening programme and AAA surveillance group over a two-year period. Cardiopulmonary exercise test and survival prediction when AAA reaches 4.5 cm. (Current clinical practice). 9 week structured exercise programme. 3 sessions per week. (Intervention). Repeat cardiopulmonary exercise test and survival prediction after structured exercise programme. Advice given for on going exercise and maintenance of fitness. (Intervention). Repeat cardiopulmonary exercise test and survival prediction after 3 months after structured exercise programme. (Intervention). Pateitns are asked to complete the following questionnaires:- EQ-5D-5L and Hospital Anxiety and Depression Scale (HADS) before, after the last exercise session and 3 months after the exercise programme. Change in medical or drug history. Change in weight or smoking.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Structured Exercise Programme
Arm Type
Experimental
Arm Description
An initial 45 min exercise counselling incorporating behaviour modification techniques. Participants will be offered three sessions per week of aerobic interval exercise on a cycle ergometer over nine weeks. Exercise programmes will be tailored to each patient, taking previous level of activity, mobility and any barriers to exercise into consideration. Following this: Participants will be encouraged to comply with current physical activity recommendations: 150 min of moderate intensity aerobic exercise per week (brisk walking / cycling). They will also be sign posted to local exercise facilities.
Intervention Type
Other
Intervention Name(s)
Structured exercise programme
Other Intervention Name(s)
Qualitiative interviews and questionnaires
Intervention Description
9 week structured exercise programme. 3 sessions per week. (Intervention).The patient will be invited to the hospital for a 45-minute exercise counselling session, incorporating behaviour modification techniques. These behaviour modification techniques will be reinforced during the supervised exercise sessions. Participants will be offered 3 sessions of supervised aerobic interval exercise sessions per week on a cycle ergometer for 9 weeks.Exercise programmes will be tailored to each patient, taking previous level of activity, mobility and any barriers to exercise into consideration.
Primary Outcome Measure Information:
Title
Change in predicted mortality: 30- day postoperative mortality (%) or median survival (years).
Description
We can predict survival after planned abdominal aortic aneurysm (AAA) surgery using physical fitness measured with a cardiopulmonary exercise test, age and comorbidities. We have validated this in a published peer reviewed multicentre study. We will measure patient's fitness before and after a structured exercise programme and assess if there is any change in their predicted survival. The primary objective of the study is to measure the change in predicted survival for abdominal aortic aneurysm surgery after a structured exercise programme.
Time Frame
3 months post end of exercise programme
Secondary Outcome Measure Information:
Title
Change in Health related Quality of Life (HRQoL) scores
Description
Metric: Completion of EuroQol EQ5D-5L questionnaires before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Time Frame
1 week and 3 months post end of exercise programme
Title
Change in Psychological Health Status
Description
Metric: Completion of Hospital Anxiety and Depression (HAD) questionnaire before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Time Frame
1 week and 3 months post end of exercise programme
Title
Change in weight
Description
Metric: Change in weight before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Time Frame
1 week and 3 months post end of exercise programme
Title
Change in cardiopulmonary exercise test
Description
Metric: Change in cardiopulmonary fitness variables (VO2, anearobic threshold, VE/VCO2,oxygen pulse), as measured using an incremental Cardiopulmonary exercise test (CPET) before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Time Frame
1 week and 3 months post end of exercise programme
Title
Change in smoking status
Description
Metric: Change in smoking habits (stopped, reduced) before the structured exercise programme, within a week of the end of the exercise programme and 3 months after the end of the exercise programme
Time Frame
1 week and 3 months post end of exercise programme

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male participants ≥ 18 Under surveillance as part of the AAA screening or surveillance programme with an AAA that is between 4.5 cm and 5.4 cm Able and willing to provide informed consent Understand verbal and written instructions in English Able to safely perform a cardiopulmonary exercise test (this will confirm they can use a cycle ergometer) Patients who are already participating (or have participated) in other trials may be eligible, but the relevant trial teams must agree this in advance.- Exclusion Criteria: Contra-indications to exercise (lower limb amputation without prosthesis, bone, joint or muscle problem which may be exacerbated by exercise, chronic lung disease causing desaturation with exercise or shortness of breath at rest, severe psychiatric health problems) Cardiovascular contra-indications (unstable angina, acute left ventricular failure, uncontrolled cardiac arrhythmias, uncontrolled hypertension, cardiac event in the previous 6 weeks, cerebral vascular accident in the previous 6 weeks) Participation in other treatment trials, where this has not been agreed in advance with both trial teams Symptomatic AAA Urgency of surgery for AAA precludes undertaking exercise programme. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Swart
Phone
01803 654310
Email
michael.swart@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona Roberts
Phone
01803 656635
Email
fiona.roberts@nhs.net
Facility Information:
Facility Name
Torbay Hospital
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Roberts
Email
fiona.roberts@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery

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